Efficacy, Safety, Tolerability, and Pharmacokinetics of Sotrastaurin Combined With Tacrolimus vs. a Mycophenolic Acid-tacrolimus Regimen in Renal Transplant Patients
Public ClinicalTrials.gov record NCT01064791. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Partially Blinded, Prospective, Randomized Multicenter Study Evaluating Efficacy, Safety and Tolerability of Oral Sotrastaurin Plus Standard or Reduced Exposure Tacrolimus vs. Mycophenolic Acid Plus Tacrolimus in de Novo Renal Transplant Recipients
Study identification
- NCT ID
- NCT01064791
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Lead sponsor
- Novartis Pharmaceuticals
- Industry
- Enrollment
- 298 participants
Conditions and interventions
Conditions
Interventions
- sotrastaurin (Dose 1) + tacrolimus + standard of care medications Drug
- sotrastaurin (Dose 2) + tacrolimus + standard of care medications Drug
- sotrastaurin (Dose 3) + tacrolimus + standard of care medications Drug
- mycophenolic acid + tacrolimus + standard of care medications Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 30, 2009
- Primary completion
- Jul 31, 2012
- Completion
- Jul 31, 2012
- Last update posted
- Dec 21, 2020
2009 – 2012
United States locations
- U.S. sites
- 7
- U.S. states
- 5
- U.S. cities
- 6
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Novartis Investigative Site | Birmingham | Alabama | 35233 | — |
| Novartis Investigative Site | Aurora | Colorado | 80045 | — |
| Novartis Investigative Site | Ann Arbor | Michigan | 48109 | — |
| Novartis Investigative Site | Detroit | Michigan | 48202-2689 | — |
| Novartis Investigative Site | Cincinnati | Ohio | 45219 | — |
| Novartis Investigative Site | Cincinnati | Ohio | 45267-0585 | — |
| Novartis Investigative Site | Madison | Wisconsin | 53792 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 37 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01064791, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 21, 2020 · Synced Jul 22, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01064791 live on ClinicalTrials.gov.